Stroke Patients With Symptomatic Intracranial Atherosclerotic StenosisPhase 3EAST-ICASNCT05741086
Evolocumab Added to Statin Therapy in Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)
A Phase 3 study testing Evolocumab and Atorvastatin in people with Stroke Patients With Symptomatic Intracranial Atherosclerotic Stenosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The primary goal of the trial is to investigate whether the experimental arms (receiving the Proprotein Convertase Subtilisin-Kexin Type 9 [PCSK9] inhibitor Evolocumab plus statin) could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke Patients With Symptomatic Intracranial Atherosclerotic Stenosis
- What is being tested?
- Evolocumab and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2023to 31 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years and ≤ 75 years.
- TIA or Acute ischemic stroke that occurred within 6 weeks prior to randomization.
- Modified Rankin score of ≤ 4.
- TIA or acute ischemic stroke attributed to a 50 to 99% stenosis of a major intracranial artery (internal carotid artery [ICA], vertebral artery [VA], basilar artery [BA] and the M1 segment of middle cerebral artery [MCA]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using high resolution MR.
- To increase the likelihood that the symptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
- insulin dependent diabetes for at least 15 years. ii. at least 2 of the following atherosclerotic risk factors: hypertension (Blood pressure [BP] ≥ 140/90 or on antihypertensive therapy); dyslipidemia (LDL ≥ 130 mg /dl or high density lipoprotein (HDL) < 40 mg/dl or fasting triglycerides ≥150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event.
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- history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease.
- any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic. v. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography.
- any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic.
- Patient agrees with follow-up visits and is available by phone.
- Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Who cannot join
- Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization).
- Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for target vessels/plaques. In case that patients who receive surgeries during follow-up, they will still be followed up for 1 year.
- Intracranial tumor (except meningioma) or any intracranial vascular malformation.
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).
- Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebral spinal fluid pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus.
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
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- Use of cholesteryl ester transfer protein (CETP) inhibition treatment, mipomersen, or lomitapide within 12 months prior to randomization. Fenofibrate therapy must be stable for at least 6 weeks prior to final screening at a dose that is appropriate for the duration of the study in the judgment of the investigator. Other fibrate therapy (and derivatives) are prohibited.
- Prior use of PCSK9 inhibition treatment before this recruitment.
- Known allergy or contraindication to aspirin, clopidogrel, evolocumab or atorvastatin.
- Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, international normalized ratio (INR) > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (aspartate transaminase [AST] or alanine transaminase [ALT] > 3 x normal, cirrhosis), creatine kinase > 5 times the upper limit of normal (ULN) at final screening, severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20mL/min/1.73 square meter at final screening.
- Major surgery (including open femoral, aortic, cardiac or carotid surgery) within previous 30 days or planned in the 1 year after enrollment.
- Dementia or psychiatric problem that prevents the patient from relevant evaluation or follow-up reliably.
- Co-morbid conditions that may limit survival to less than 1 year.
- Currently breastfeeding, pregnancy, planning to become pregnant and unwilling to use contraception for the duration of this study
- Enrollment in another study that would conflict with the current study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210001
Zhaolu Wang, MD, PhD, 18100613663, wangzhaolu123@163.com
About this study
Official title: Evolocumab Added to Statin Therapy in Patients With Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)---a Pilot Study
The primary goal of the trial is to investigate whether the experimental arms (receiving the Proprotein Convertase Subtilisin-Kexin Type 9 [PCSK9] inhibitor Evolocumab plus statin) could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up, compared with the control arm (taking statin) in patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis.
Read the detailed description
Intracranial atherosclerosis stenosis (ICAS) is one of the most common causes of stroke worldwide and is particularly prevalent in Asian. It accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (Intensive lipid lowering with statin to reach a low-density lipoprotein (LDL)-cholesterol lower than 1.8mmol/L, et al) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group.
Evolocumab, a member of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. The FOURIER study showed that Evolocumab reduced the risk of cardiovascular events (e.g. cardiovascular death, myocardial infarction and stroke), in patients with atherosclerotic cardiovascular disease.
The proposed pilot study will recruit 80 patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis, and directly compare Evolocumab on top of statin with statin therapy in changes of intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up.
- Being tested
- Evolocumab, Atorvastatin
- Keywords
- Evolocumab, stroke, intracranial atherostenosis stenosis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
evolocumab (140 mg every 2 weeks)
AtorvastatinDrug
Atorvastatin 20-40mg
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab added to statin therapy | Experimental | Evolocumab (140 mg every 2 weeks for 1 year) added to statin (Atorvastatin 20-40mg). Anti-platelet aggregation and risk factor management in both arms. Receives: Drug: Evolocumab; Drug: Atorvastatin |
| Statin therapy | Active comparator | Atorvastatin 20-40mg. Anti-platelet aggregation and risk factor management in both arms. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque burden (PB)
lumen area (LA) is manually contoured on T1-weighted SPACE at the most stenotic site (LAplaque). PB is calculated as (1 - LAplaque/OWAplauqe) × 100%
Measured: This will be assessed at 1 year after recruitment.
Degree of stenosis caused by the plaque
degree of stenosis = (1 - Dplaque/Dreference) × 100%, where Dplaque indicated the diameter of the culprit artery at the most stenotic site, and Dreference was the diameter of the normal artery proximal to the plaque
Measured: This will be assessed at 1 year after recruitment.
Plaque enhancement
grading of plaque enhancement: grade 0 indicated enhancement is similar to or less than that of normal-appearing intracranial arterial walls in the same individual; grade 1, enhancement is greater than that of grade 0 but less than that of the pituitary infundibulum; and grade 2, enhancement is similar to or greater than that of the infundibulum. plaque enhancement ratio (ER): circular region of interest (ROI) was drawn within the plaque on pre-contrast and post-contrast T1-weighted SPACE images, respectively. The mean signal intensity (SI) of plaques were obtained. ER = (SIpost - SIpre)/SIpre ×100%
Measured: This will be assessed at 1 year after recruitment.
Remodeling index (RI) of the plaque
the outer wall area (OWA) is manually contoured on T1-weighted SPACE at the most stenotic site (OWAplaque) and the reference site (OWAreference). RI is calculated as OWAplaque/OWAreference × 100%. Arterial remodeling is categorized as positive if RI > 1.05, intermediate if 0.95 ≤ RI ≤ 1.05, and negative if RI < 0.95;
Measured: This will be assessed at 1 year after recruitment.
Presence of T1 hyperintensity in the plaque
the brightest spot of the plaque with SI >150% of that of the reference vessel wall on pre-contrast T1 image
Measured: This will be assessed at 1 year after recruitment.
Plaque distribution: whether it is a concentric plaque or not
a concentric plaque is defined if the wall involvement was more than 75%, and the minimum wall thickness is higher than 50% of the maximum wall thickness.
Measured: This will be assessed at 1 year after recruitment.
Hemodynamic characteristics: Hypoperfusion volume
dynamic susceptibility contrast-perfusion weighted imaging (DSC-PWI) performed and computed using the singular value decomposition deconvolution method using a commercial software NeuBrainCARE (v1.1.10). Hypoperfusion volume on the ipsilateral side of stroke were automatically calculated by use of time to maximum (Tmax) with time thresholds of > 4 seconds and > 6 seconds, respectively.
Measured: This will be assessed at 1 year after recruitment.
Secondary outcomes (2)
any stroke (ischemic or hemorrhagic) or death during 1 year of follow-up in an intention-to treat analysis.
Measured: This will be assessed during the first year of follow-up.
Changes in LDL-cholesterol levels
Measured: This will be assessed during the first year of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start15 Apr 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke Patients With Symptomatic Intracranial Atherosclerotic StenosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Hua, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Hua Lu, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741086
- Sponsor's protocol ID
- EAST-ICAS
- Acronym
- EAST-ICAS
- Status last verified
- Jun 2023
- First submitted
- 14 Feb 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
Publications
Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
PubMed 24135208Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.
PubMed 24168957Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
PubMed 28304224Dai J, Zhao H, Chen X, Nie P, Gong J, Wang M, Zhang K, Wang Z, Lu H. Design of the "EAST" strategy in patients with symptomatic intracranial atherosclerotic stenosis. Front Neurol. 2025 May 9;16:1520356. doi: 10.3389/fneur.2025.1520356. eCollection 2025.
PubMed 40417113
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolocumab Added to Statin Therapy in Patients With Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)---a Pilot Study
- ClinicalTrials.gov ID
- NCT05741086
- Acronym / sponsor ID
- EAST-ICAS / EAST-ICAS
- Keywords
- Evolocumab, stroke, intracranial atherostenosis stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the trial is to investigate whether the experimental arms (receiving the Proprotein Convertase Subtilisin-Kexin Type 9 [PCSK9] inhibitor Evolocumab plus statin) could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up, compared with the control arm (taking statin) in patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis.
Detailed description
Intracranial atherosclerosis stenosis (ICAS) is one of the most common causes of stroke worldwide and is particularly prevalent in Asian. It accounts for up to 30-50% of strokes amongst Asian patient cohorts, in contrast to 5-10% of strokes amongst western patient cohorts. The SAMMPRIS established aggressive medical management (Intensive lipid lowering with statin to reach a low-density lipoprotein (LDL)-cholesterol lower than 1.8mmol/L, et al) as a superior choice for symptomatic ICAS compared to the percutaneous transluminal angioplasty and stenting. However, around 15% still had recurrent stroke or death during a median follow-up of 32.4 months in SAMMPRIS study in the aggressive medical management group.
Evolocumab, a member of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. The FOURIER study showed that Evolocumab reduced the risk of cardiovascular events (e.g. cardiovascular death, myocardial infarction and stroke), in patients with atherosclerotic cardiovascular disease.
The proposed pilot study will recruit 80 patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis, and directly compare Evolocumab on top of statin with statin therapy in changes of intracranial atherosclerotic plaque and hemodynamic features during 1 year of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients meeting the enrollment criteria will be randomly assigned to one of the two treatment groups (1:1) and will be followed up for 1 year.
| Arm | Type | Receives |
|---|---|---|
| Evolocumab added to statin therapy | Experimental | Drug: Evolocumab, Drug: AtorvastatinEvolocumab (140 mg every 2 weeks for 1 year) added to statin (Atorvastatin 20-40mg). Anti-platelet aggregation and risk factor management in both arms. |
| Statin therapy | Active comparator | Drug: AtorvastatinAtorvastatin 20-40mg. Anti-platelet aggregation and risk factor management in both arms. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 30 years and ≤ 75 years.
- TIA or Acute ischemic stroke that occurred within 6 weeks prior to randomization.
- Modified Rankin score of ≤ 4.
- TIA or acute ischemic stroke attributed to a 50 to 99% stenosis of a major intracranial artery (internal carotid artery [ICA], vertebral artery [VA], basilar artery [BA] and the M1 segment of middle cerebral artery [MCA]). The diagnostic evaluation for ICAS at each site is confirmed by the local investigator, using high resolution MR.
- To increase the likelihood that the symptomatic intracranial stenosis is atherosclerotic, patients aged 30-49 years are required to meet at least one additional criteria (i-vi) below:
Key exclusion criteria (15 listed)
- Previous treatment of target intracranial lesion with a stent, angioplasty, or other mechanical devices (e.g. mechanical thrombectomy, coil embolization).
- Plan to perform angioplasty, stenting, coiling, thrombectomy, endarterectomy or aneurysmal coil embolization for target vessels/plaques. In case that patients who receive surgeries during follow-up, they will still be followed up for 1 year.
- Intracranial tumor (except meningioma) or any intracranial vascular malformation.
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural).
- Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebral spinal fluid pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evolocumabevolocumab (140 mg every 2 weeks) | Drug | Evolocumab added to statin therapy |
| AtorvastatinAtorvastatin 20-40mg | Drug | Evolocumab added to statin therapy, Statin therapy |
Primary outcome
Plaque burden (PB)
Time frame: This will be assessed at 1 year after recruitment.
lumen area (LA) is manually contoured on T1-weighted SPACE at the most stenotic site (LAplaque). PB is calculated as (1 - LAplaque/OWAplauqe) × 100%
Degree of stenosis caused by the plaque
Time frame: This will be assessed at 1 year after recruitment.
degree of stenosis = (1 - Dplaque/Dreference) × 100%, where Dplaque indicated the diameter of the culprit artery at the most stenotic site, and Dreference was the diameter of the normal artery proximal to the plaque
Plaque enhancement
Time frame: This will be assessed at 1 year after recruitment.
grading of plaque enhancement: grade 0 indicated enhancement is similar to or less than that of normal-appearing intracranial arterial walls in the same individual; grade 1, enhancement is greater than that of grade 0 but less than that of the pituitary infundibulum; and grade 2, enhancement is similar to or greater than that of the infundibulum. plaque enhancement ratio (ER): circular region of interest (ROI) was drawn within the plaque on pre-contrast and post-contrast T1-weighted SPACE images, respectively. The mean signal intensity (SI) of plaques were obtained. ER = (SIpost - SIpre)/SIpre ×100%
Remodeling index (RI) of the plaque
Time frame: This will be assessed at 1 year after recruitment.
the outer wall area (OWA) is manually contoured on T1-weighted SPACE at the most stenotic site (OWAplaque) and the reference site (OWAreference). RI is calculated as OWAplaque/OWAreference × 100%. Arterial remodeling is categorized as positive if RI > 1.05, intermediate if 0.95 ≤ RI ≤ 1.05, and negative if RI < 0.95;
Presence of T1 hyperintensity in the plaque
Time frame: This will be assessed at 1 year after recruitment.
the brightest spot of the plaque with SI >150% of that of the reference vessel wall on pre-contrast T1 image
Plaque distribution: whether it is a concentric plaque or not
Time frame: This will be assessed at 1 year after recruitment.
a concentric plaque is defined if the wall involvement was more than 75%, and the minimum wall thickness is higher than 50% of the maximum wall thickness.
Hemodynamic characteristics: Hypoperfusion volume
Time frame: This will be assessed at 1 year after recruitment.
dynamic susceptibility contrast-perfusion weighted imaging (DSC-PWI) performed and computed using the singular value decomposition deconvolution method using a commercial software NeuBrainCARE (v1.1.10). Hypoperfusion volume on the ipsilateral side of stroke were automatically calculated by use of time to maximum (Tmax) with time thresholds of > 4 seconds and > 6 seconds, respectively.
2 secondary outcomes
any stroke (ischemic or hemorrhagic) or death during 1 year of follow-up in an intention-to treat analysis.
Time frame: This will be assessed during the first year of follow-up.
Changes in LDL-cholesterol levels
Time frame: This will be assessed during the first year of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Background: PubMed 24135208Holmstedt CA, Turan TN, Chimowitz MI. Atherosclerotic intracranial arterial stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2013 Nov;12(11):1106-14. doi: 10.1016/S1474-4422(13)70195-9.
- Background: PubMed 24168957Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.
- Background: PubMed 28304224Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
- Derived from this study: PubMed 40417113Dai J, Zhao H, Chen X, Nie P, Gong J, Wang M, Zhang K, Wang Z, Lu H. Design of the "EAST" strategy in patients with symptomatic intracranial atherosclerotic stenosis. Front Neurol. 2025 May 9;16:1520356. doi: 10.3389/fneur.2025.1520356. eCollection 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Lu, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evolocumab and Atorvastatin in people with Stroke Patients With Symptomatic Intracranial Atherosclerotic Stenosis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaolu Wang, MD (18100613663, wangzhaolu123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque burden (PB) (time frame: This will be assessed at 1 year after recruitment.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741086, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.